Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Wednesday, July 26, 2006

The Shape of the Financial Arrangements Behind the Publication of the SHAPE Guidelines

The Boston Globe uncovered a new way in which researchers, medical journals, and pharmaceutical firms can get entangled.

The SHAPE Task Force is apparently a group of cardiologists who strongly advocate high-technology screening to detect asymptomatic coronary artery disease (CAD). The Task Force wrote a guideline to this effect, even though, per the Globe, "the authors concede [the guideline] is not supported by rock-solid evidence." Unable to get official support from the American Heart Association or the American College of Cardiology, they asked the AJC to publish it in a special supplement. So,

Journal editor Dr. William C. Roberts told the group that, in contrast to how it works in the regular pages of the magazine, if they wanted their recommendations published, they 'would have to have some financial support.'

Dr. Morteza Naghavi, lead author of the guidelines, sent letters soliciting aid to six drug companies. In the letters, which Naghavi supplied to the Globe, he writes that 'the report will be distributed to 100,000 physicians worldwide.'

Naghavi received a favorable response from Pfizer Inc, whose funding of the report is noted in the journal. In an e-mailed answer to an inquiry from The Globe about its contribution, a company spokeswoman wrote that 'Pfizer feels it is important to provide support for efforts that assess novel approaches to reduce the burden of heart disease.'

Once the authors came up with the funding from Pfizer, which summed to $55,800 according to the Globe, the AJC was willing to publish the guideline, which was thereafter "not subject to the standard review process."

According to the Globe, Pfizer's "funding of the report is noted in the journal." Furthermore, "in an appendix to the heart-screening guidelines, several authors acknowledged that they had financial arrangements or affiliations with drug companies or medical device-makers whose products might be influenced by these recommendations."

The guideline is available on the web here, along with an introduction by its authors. As best as I can tell, the versions available on the web do not include any mention of the funding by Pfizer, the financial arrangements of the authors noted above, or any notice that the guidelines were not subject to the standard peer-review process. Several of the guideline authors were listed as Pfizer employees. (ADDENDUM, 24 August, 2006: A comment below suggests that the Pfizer funding is disclosed in the print edition of the journal. I do not have access to the print version, so cannot confirm this, but have no reason to doubt it.)

The guidelines themselves advocated the use of the coronary artery calcification score (CACS) determined by computed tomography (CT) scanning, and the carotid [artery] intima-media thickness (CIMT) determined by ultrasound as screening tests to detect CAD. Although the guidelines were based on extensive citations in the literature, they were not developed using an explicit evidence based medicine process. In particular, the authors did not systematically survey all the relevant literature, and did not critically review the most pertinent articles.

The criteria the guidelines used for recommending screening tests were

(1) the abundance of evidence for the predictive value of the test in the recommended
population over and above that available from standard office-based risk assessment tools (incremental value), (2) availability, (3) reproducibility, (4) complementary
value with respect to the concept of the vulnerable patient, and/or (5) cost-effectiveness relative to the status quo.

These criteria were markedly different from the criteria used by the conservative and evidence-based US Preventive Services Task Force in making screening recommendations. For example, the SHAPE Task Force guidelines seemed to ignore the sensitivity of the tests, whether there was evidence that treating asymptomatic patients whose disease was diagnosed by screening tests would provide better results than waiting to treat patients when they developed symptoms (and particularly whether aggressive treatments of large numbers of asymptomatic patients, particularly with lipid-lowering drugs, might have some adverse effects), and whether the tests, again when employed widely in a screening application, could have adverse effects (especially given the radiation dose from CT scans.)

As former New England Journal of Medicine Editor Dr Jerome Kassirer put it in the Boston Globe,"the whole thing sounds like a conflicted mess, from the recommendations that they're making to the issue of how these journal supplements work." Furthermore, not all the conflicts were disclosed, at least in the web-based version of the guidelines. On the web, the journal failed to disclose that this supplement was published without peer review and was supported by a pharmaceutical company, and that some of the authors had potential conflicts of interest.

Again, this case suggests that physicians and patients need to fully understand the financial (and other) arrangements that could affect opinion and research articles published in medical journals, even when the articles have distinguished authors and are published in reputable journals. We have now seen all manner of such arrangements affecting articles' authors, their institutions, and the journals that publish them. Many of them have gone totally undisclosed, unless discovered by enterprising journalists or academic whistle-blowers. Even those that have been disclosed have not been disclosed in sufficient detail to really evaluate their effects.

Physicians and patients now need to be extremely skeptical about whether such arrangements affect the content or arguments of seemingly scholarly articles published in even the most reputable journals, and may need to be more skeptical about articles which disclose no such arrangements than about those which at least offer some partial disclosure.

My husband, who was assymptomatic but who had multiple risk factors, died of a sudden heart attack at age 49 two years ago. There is no doubt that a CT scan would have spotted his three blocked coronary arteries, one of which was over 95% blocked and another of which was over 80% blocked. He was a lifelong non-smoker who had a 34 inch waist at the time he died, but he had a 10 year history of hyperlipidemia (high cholesterol) and a strong family history of heart disease. It is all well and good to say that it may be "better to wait to treat patients until they develop symptoms," but for many people, the first symptom of heart disease is a fatal heart attack. We now have routine screening for colon cancer, breast cancer and prostate cancer, when heart disease kills more people every year that all of those three cancers combined. There should be routine screening for heart disease in assymptomatic patients, paticularly where one or more risk factors for heart disease is present. The real reason why some doctors and insurance companies oppose this (just like they also opposed routine mamograms and colonoscopies) is because of cost. Let's work on bringing the cost down and saving lives rather than damning millions of assymptomatic patients to an early death.

In response to the comment above, I have reviewed the version of the guidelines article that is on the web (here: http://www.ajconline.org/webfiles/images/journals/ajc/execsumm.pdf/)

I still can't find disclosure of the source of the grant that funded it. Moreover, I also can't find mention of the authors' financial arrangements (beyond their employers), or a notice that the article did not go through the standard peer-review process.)

If I missed something, please let me know exactly where in the published article it was, and I will revise my post (and note the change in the comments.)

The aknowledgement of Pfizer's unrestricted eductional grant that funded the publication of the SHAPE Task Force report is printed on the first page when you open the American Journal of Cardiology edition in which it was published. The bottom line is that the critics seem to be suggesting that a $50,000 grant would prompt some of the most respected cardiologists and researchers in the world to throw away their reputations. It's ridiculous. Those who suggest that the SHAPE Task Force is somehow not qualified to make such recommendations haven't looked carefully at those involved. Those who say entities such as the American Heart Association or the American College of Cardiology are better able to make such recommendations because of their independence choose to ignore the fact that these organizations together accept tens of millions of dollars each year from pharmaceutical companies. To question the motives of this esteemed group of physicians who have waited on the sidelines for DECADES for the medical establishment to catch up to science and technology is shameful. The fact is that SHAPE or something like it is inevitable. We should be holding the SHAPE Task Force up as visionaries, not personally and professionally attacking them.

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